MAUDE Adverse Event Report: SYNTHES GMBH GUIDINGBLOCK F/LCP-PLT 4.5/5 LE; GUIDE

Catalog Number	312.941
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for the distal femoral fracture.The guiding block was deformed partially, and the surgeon could not insert the drill guide into one of the holes of the guiding block.The surgery was completed successfully without any surgical delay.The patient condition was stable.Concomitant device reported: unk - guides/sleeves/aiming: guide (part# unknown; lot# unknown; quantity:1.This complaint involves one (1) device.This report is for (1) guide block for lcp(tm) distal femur plates-left.This report is 1 of 1 (b)(4).
Additional 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: visual analysis of the returned sample revealed that guidingblock f/lcp-df 4.5/5 le one of the holes of the guiding block is slightly deformed.No other defects were identified.So the alleged deform condition can be confirmed.The dimensional inspection was not performed for the guidingblock f/lcp-df 4.5/5 le due to post manufacturing damage.The functional test was not performed as the device was received by itself.The alleged misalignment condition cannot be confirmed since the functional test cannot be performed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for guidingblock f/lcp-df 4.5/5 le.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : part: 312.947, lot: 2653488, manufacturing site: bettlach, release to warehouse date: 11.Oct.2010.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: GUIDINGBLOCK F/LCP-PLT 4.5/5 LE
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11620619
• Report Number: 8030965-2021-02622
• Device Sequence Number: 19749720
• Product Code: FZX
• UDI-Device Identifier: 07611819286368
• UDI-Public: 07611819286368
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 312.941
• Device Lot Number: 2653486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDES/SLEEVES/AIMING: GUIDE