MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 24MM F/IM NAILS-STER ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.005.414S

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Event date: 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. 0 mm ti locking screw w/t25 stardrive 24 mm f/im nails-ster. This is report 3 of 8 for (b)(4).

• Brand Name: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 24MM F/IM NAILS-STER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8696194
• MDR Text Key: 147909189
• Report Number: 8030965-2019-65243
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• 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

• Device Catalogue Number: 04.005.414S
• Device Lot Number: 3L86080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2019
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 06/13/2019 Patient Sequence Number: 1