MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM/3.5MM TI VA-LCP LAT DSTL HUM PL 1H/RT/69MM SHRT-STER; PLATE FIXATION, BONE

Catalog Number 04.117.801S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: hwc.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 (b)(6) 2020, the patient underwent the open reduction internal fixation (orif) surgery for distal humeral fractures by using 2.7 mm va lcp elbow system.During the surgery, when the surgeon tried to fix the plate with the locking screw, but he could not tighten the locking screw while it turned idle.He changed inserting angle of the locking screw and tried to insert it, but he could not tighten it.He removed the plate and checked whether the locking screw could be tightened or not, but the locking screw could not be tightened.Surgeon used another plate and the locking screw,to complete the procedure.The surgery was successfully completed with a sixty (60) minute surgical delay.Patient outcome is reported as stable.No further information is available.Concomitant device reported: va lockscr ø2.7 head 2.4 self-tap l30 ta (part # 04.211.030s, lot # 1l77561, quantity 1).This report is for one (1) 2.7mm/3.5mm ti va-lcp lat dstl hum pl 1h/rt/69mm shrt-ster.This is report 1 of 2 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.H3, h4, h6: part 04.117.801s, lot h700967: manufacturing location: elmira / packaged, sterilized and released by: monument.Release to warehouse date: august 15, 2018.Expiration date: august 01, 2028.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.H3, h6: a product investigation was completed: a visual inspection of the device showed that the anodize layer has been removed (stripped) on the threads of all variable angle holes.Functional testing was performed; it was observed that the screw could not be tightened into any of the variable angle locking holes.Dimensional inspection could not be performed as the thread were damaged post-manufacturing.The relevant drawing was reviewed; no design issues or discrepancies were found during this investigation.The manufacturer conducted a review of the device history record (dhr) and found that no manufacturing related issues were observed.This lot met all dimensional and visual criteria at the time of release for shipment with no issues documented that would contribute to the complaint condition.The complaint was confirmed as the 2.7mm variable angle locking screw could not be tightened into any of the variable angle locking holes as the threads were found stripped.The manufacturing investigation also determined the complaint condition was confirmed as the damage to the threads was consistent with screw implantation performed during surgery.A definitive root cause could not be determined based on the provided information, but it is likely that the threads could have been damaged due to the application of excessive forces.During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: 2.7MM/3.5MM TI VA-LCP LAT DSTL HUM PL 1H/RT/69MM SHRT-STER
• Type of Device: PLATE FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10548066
• MDR Text Key: 207404424
• Report Number: 8030965-2020-07158
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819506169
• UDI-Public: (01)07611819506169
• Combination Product (y/n): N
• PMA/PMN Number: K120070
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.117.801S
• Device Lot Number: H700967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 11/09/2020
• Patient Sequence Number: 1
• Treatment: VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L30 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L30 TA