MAUDE Adverse Event Report: SYNTHES GMBH PFNA BLADE PERF L105 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.036S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer 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 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)(4) as follows: it was reported that on (b)(6), 2021, during a procedure the pfna blade could not be locked after insertion.There was a surgical delay of five (5) minutes.The procedure was completed successfully.There was no patient consequence.This report involves one (1) pfna blade perf l105 tan.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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, h6: the device was 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.

Manufacturer Narrative

Product complaint #: (b)(4).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 flow: functional.Visual inspection: the complaint devices pfna blade (product code: 04.027.036s, lot number: 220p069) along with impactor for pfna blade was returned to cq west chester for investigation.The impactor for pfna blade will be investigated under (b)(4).The pfna blade was still attached to the impactor and had been scratched.Functional test: a functional test to remove the impactor and the pfna blade was performed.The lock and attach assembly on the impactor was stuck and could not be moved even after several tries.Hence, the pfna nail was stuck on the impactor.The complaint condition can be replicated during functional test.The complaint condition can be confirmed during physical device investigation.Dimensional inspection: a dimensional inspection was not performed as the internal components of the device could not be accessed without the destruction of the device.Document/specification review: based on the date of manufacture, the current and manufactured version of drawing were reviewed.Conclusion: the impactor shaft had become stuck to the pfna blade and the two devices could not be disassembled during functional test.Hence, the complaint was confirmed.A definitive assignable root cause could not be determined from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.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: product code: 04.027.036s; lot number: 220p069; manufacturing site: bettlach; release to warehouse date: 22 june 2021; expiry date: 01 june 2031.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was 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: PFNA BLADE PERF L105 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12589315
• MDR Text Key: 281278866
• Report Number: 8030965-2021-08460
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819369504
• UDI-Public: (01)07611819369504
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.036S
• Device Lot Number: 220P069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS: TRAUMA.; UNK - NAILS: PFNA.