MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CANNULATED CONNECTING SCREW F/ TI CANNULATED HUMERAL NAILS-EX; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.053
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).Device history lot.Part/lot (03.010.053 / s34) combination are unknown at synthes (b)(4), no dhr review possible.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent a removal surgery of expert humeral nail bone union was confirmed.During the surgery, the surgeon could not connect the connecting screw to the nail.The device couldn¿t insert straight to the nail because soft part tissue was in the way.The surgery was finished with the nail remained in the patient.The surgery was delayed by 100 minutes.The patient outcome was unknown.This complaint involves two (2) devices.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history: part/lot (03.010.053 / s34) combination are unknown at synthes gmbh, no dhr review possible.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.

• Brand Name: CANNULATED CONNECTING SCREW F/ TI CANNULATED HUMERAL NAILS-EX
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9978439
• Report Number: 8030965-2020-02943
• Device Sequence Number: 2208959
• Product Code: LXH
• UDI-Device Identifier: 07611819796393
• UDI-Public: (01)07611819796393
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.053
• Device Lot Number: S34
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 05/11/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONNECSCR CANN F/EXPERT HN; UNK - NAILS: EXPERT HUMERAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Weight: 100