MAUDE Adverse Event Report: SYNTHES GMBH 9.5MM TI MULTILOC PROX HUMERAL NAIL/LT/CANN/160MM-STER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.016.039S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review investigation.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 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 Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 an open reduction internal fixation surgery was performed for two (2) fractures of the left humorous.During the surgery, the surgeon tried to insert the nail without reaming, however he had difficulty inserting it because the medullary cavity was narrower than he'd thought.The devices for reaming had not be prepared so the surgeon inserted the nail by tapping with a hammer and the secondary fracture occurred.The secondary fracture was reduced as much as possible and another nail (8mm diameter) was inserted.The procedure was completed with 60 minutes delay.Concomitant device reported: unk - impaction inst: hammer/mallet: (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) 9.5mm ti multiloc prox humeral nail/lt/cann/160mm-ster.This is report 1 of 1 for (b)(4).

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.H10 additional narrative: h3, h4, h6- product complaint #: (b)(4).Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 lot: part # 04.016.039s; lot # 67p7799; manufacturing site: mezzovico; release to warehouse date: 05 nov 2020; expiry date: 01.Oct.2025.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device history batch: null.Device history review: null.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: 9.5MM TI MULTILOC PROX HUMERAL NAIL/LT/CANN/160MM-STER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11495400
• MDR Text Key: 253177296
• Report Number: 8030965-2021-02023
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.016.039S
• Device Lot Number: 67P7799
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2021
• Patient Sequence Number: 1
• Treatment: UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA.
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR