MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM TI MULTILOC SCREWLENGTH 40MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.019.040S

Device Problem No Apparent Adverse Event (3189)

Patient Problems Nerve Damage (1979); Paralysis (1997)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown date in 2019.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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient had a radial nerve paralysis as confirmed by the facility.Initially, the patient was implanted with a multiloc humeral nail in question on (b)(6) 2019.There were four (4) multiloc screws used in the proximal locking and three (3) locking screws used on the distal locking.The facility plans a reoperation on (b)(6) 2019 and in the reoperation, a large skin incision will be made and necessary procedures will be done according to the condition of the nerve pathways.This report is for one (1) 4.5mm ti multiloc screwlength 40mm-sterile.This is report 7 of 8 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.Part: 04.019.040s, lot: 3l49310, manufacturing site: grenchen, release to warehouse date: 22.February 2019, expiry date: 01.February 2029.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.

• Brand Name: 4.5MM TI MULTILOC SCREWLENGTH 40MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8696307
• MDR Text Key: 148012700
• Report Number: 8030965-2019-65247
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819430648
• UDI-Public: (01)07611819430648
• 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
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.019.040S
• Device Lot Number: 3L49310
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention