MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for CALIPER IN & OUT DIA TO 150MM AA846R manufactured by Aesculap Ag.
[140922621]
(b)(4). Manufacturing site evaluation: investigation: the caliper was available for investigation decontaminated. The caliper was in mint condition, but one of the adjustment screws was not in place. The screw is not available. Batch history review: a review of the device quality and manufacturing history records was not possible because the lot number is unknown. Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage. Rationale: the adjustment screws are necessary to adjust the movement of the sliding part of the caliper, thus they need to be moveable. According to the instructions for use (ifu), the instrument must be checked prior to each use for loosened components: inspection, maintenance and checks: after each complete cleaning, disinfecting and drying cycle, check that the product is dry, clean, operational, and free of damage. Check that the product functions correctly. Immediately put aside damaged or inoperative products and send them to aesculap technical service. A capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[140922622]
It was reported there was an intraoperative issue with the caliper. During a hip surgery, it was noted that the screw was missing from the caliper. The caliper was being used on the back table and not directly in the operative field. The reporter felt that the screw becomes loose and separates too easily. There was no patient harm and an x-ray was not required. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00201 |
| MDR Report Key | 8480380 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-03 |
| Date Facility Aware | 2019-03-21 |
| Date Mfgr Received | 2019-03-11 |
| Date Added to Maude | 2019-04-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CALIPER IN & OUT DIA TO 150MM |
| Generic Name | BASIC INSTRUMENTS |
| Product Code | KTZ |
| Date Received | 2019-04-03 |
| Returned To Mfg | 2019-03-18 |
| Model Number | AA846R |
| Catalog Number | AA846R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-03 |