MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw.Part and lot numbers are unknown; udi number is unknown.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(b)(4).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 on an unknown date that the patient had 2 x 2.7 mm va screws break in a distal radius plate.The two screw shafts needed removing.The patient also needed her tendons repaired.This was potentially due to the tendons rubbing on the broken surface of the backed out screw heads.The patient had a non-union of her fracture.There was a surgical delay during the explantation of the screws of 15 minutes.Concomitant device reported: distal radius plate (part # 02.111.631, lot # l112949, quantity 1), 14mm cortex screw (part # 202.874, lot # l089415, quantity 1), 12mm cortex screw (part # 202.874, lot # l289153 and l343052, quantity 2), unknown synthes device (part # unknown, lot # unknown, quantity 2).This complaint involves two (2) devices.This is 2 of 2 for report (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.Investigation selection investigation site: cq zuchwil , selected flow: damage.Visual inspection: the two (2) screws were found broken between the shaft and their screw-heads.The threaded parts are damaged at the thread flanks.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: dimensional analysis could not be performed as relevant features are deformed through post manufacturing damage.Document/specification review: a ¿document/specification review¿ is not possible, as no lot number nor article number got reported.Conclusion: our investigation has shown that the complaint condition for the broken screws is confirmed.Because of the damage, it is not possible to measure the relevant dimension.Based on the provided information we are not able to determine the exact cause of this breakage.We can only assume that any occurrence during the healing process, e.G.Non-union, delayed union, mal-union, overloading of the osteosynthesis or a combination of different factors, did lead to a fatigue failure.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 as no product related issue could be detected 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: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9654500
• MDR Text Key: 190760072
• Report Number: 8030965-2020-00776
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Date Manufacturer Received: 02/27/2020
• Patient Sequence Number: 1
• Treatment: 2.7MM CRTX SCR S/TAP T8 12MM; 2.7MM CRTX SCR S/TAP T8 14MM; UNKNOWN SYN PRODUCT; VA-LCP-2-COLUMN DRP2.4 VOLAR LE SHAFT 3H
• Patient Outcome(s): Required Intervention