FDA.reportPublic FDA data

MAUDE MDR 9889187

MDR report key
9889187
Report number
2939274-2020-01567
Event key
0
Event type
3
Date received
2020-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARA DITTY-BOVARD
Address
1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
Phone
610-610-6103
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NAIL EXTRACTORROD,FIXATION,INTRAMEDULLARYWRIGHTS LANE SYNTHES USA PRODUCTS LLCHSB03.037.03203.037.0329237381* R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-270

Event Narratives#

N

Patient 1

INVESTIGATION SUMMARY: INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE NAIL EXTRACTOR (P/N # 03.037.032, L/N # 9343591) WAS RECEIVED AT US CQ WITH THE DISTAL THREADS STRIPPED. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS COMPLETED. CONCLUSION: A DEFINITIVE ASSIGNABLE ROOT CAUSE FOR THE POST MANUFACTURING DAMAGE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED BECAUSE OF THIS EVALUATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT. PART: 03.037.032. LOT: 9237381. MANUFACTURING SITE: (B)(6). RELEASE TO WAREHOUSE DATE: (B)(6), 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

D

Patient 1

IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION AT THE STERILE PROCESSING DEPARTMENT (SPD), A DRIVING CAP, RADIOLUCENT INSERTION HANDLE, HELICAL BLADE EXTRACTOR AND NAIL EXTRACTOR WERE NOTED TO HAVE AN UNKNOWN MALFUNCTION. THE DRIVING CAP AND THE INSERTION HANDLE WHERE BROKE AT THE CONNECTION OF THE TWO AND THE HELICAL BLADE EXTRACTION AND THE EXACTION NAIL WERE BOTH STRIPPED AT THE THREADS. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE DEVICES. THIS IS REPORT 3 OF 3 FOR (B)(4).