MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for GLENOSPHERE ORIENTATION GUIDE 230795000 manufactured by Depuy France Sas 3003895575.
[118553418]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[118553419]
Instrument room technician was assembly set for sterilization when she noted the tip of glenospher orientation guide was cracked almost broken off - item number 230795000. Supervisor decided to check other instrument set to see if that orientation guide was ok and found it also had a crack. (b)(4) has issued for this replacement. Patient consequence? No. Action taken for procedure:instrument defect was not noted during a surgical procedure. Is the information being submitted for this complaint all the details that are known/available regarding this event? Yes.
Patient Sequence No: 1, Text Type: D, B5
[124837156]
Product complaint # pc-(b)(4). Investigation summary examination of the returned device confirmed the reported cracking. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[124873650]
Product complaint # : (b)(4). Examination of the returned device confirmed the reported cracking. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[128729140]
Product complaint #: (b)(4). Investigation summary: examination of the returned device confirmed the reported cracking. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2018-67777 |
| MDR Report Key | 7819157 |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-09-27 |
| Device Manufacturer Date | 2011-05-30 |
| Date Added to Maude | 2018-08-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465820988 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS INC 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GLENOSPHERE ORIENTATION GUIDE |
| Generic Name | EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES |
| Product Code | LXO |
| Date Received | 2018-08-27 |
| Returned To Mfg | 2018-09-21 |
| Catalog Number | 230795000 |
| Lot Number | 5081533 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY FRANCE SAS 3003895575 |
| Manufacturer Address | 7 ALL?E IR?NE JOLIOT CURIE BP 256 SAINT PRIEST CEDEX 69801 FR 69801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-27 |