MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR Ø5 L56 F/NAILS TAN LIGHT GREEN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.005.546S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

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.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.Device evaluated by mfr and manufacture date: sterile part 04.005.546s, lot 2l26334: supplier: früh verpackungstechnik ag.Release to warehouse date: november 05, 2018.Expiration date: november 01, 2028.Non-sterile part 04.005.546, lot 2l11113: release to warehouse date: october 30, 2018.Manufacturer: mezzovico.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 (b)(6) 2021, the patient underwent the primary surgery with the expert a2fn for the segmental comminuted fracture of the diaphyseal femur.It was noted the fracture was an ao fracture classification :32c2.The surgery was completed successfully without any surgical delay.Although there were no problems with implant fixation, the patient¿s biological activation was weak and pseudoarthrosis occurred after the primary surgery.This complaint covers the post-operative pseudoarthrosis.This is related to (b)(4) which captures an issue during the revision procedure due to the pseudoarthrosis.This report is for a locking screw.This is report 4 of 6 for (b)(4).

• Brand Name: LOCKSCR Ø5 L56 F/NAILS TAN LIGHT GREEN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14687003
• MDR Text Key: 294031190
• Report Number: 8030965-2022-03960
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819789906
• UDI-Public: (01)07611819789906
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.005.546S
• Device Lot Number: 2L26334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: END-CAP F/A2FN CANN EXTENS. 5 TAN GREY; EXPERT A2FN NAIL Ø10 LE CANN L380 TAN LI; LOCKSCR Ø5 L36 F/NAILS TAN; LOCKSCR Ø5 L46 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L56 F/NAILS TAN LIGHT GREEN
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male