MAUDE Adverse Event Report: SYNTHES GMBH PFNA BLADE PERF L100 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.035S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

510 k: this report is for an unknown nail head elements: pfna blade/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was 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 Description

Device report from (b)(6) reports an event as follows: it was reported on (b)(6) 2020, that the sterile blade was stuck inside during an unknown procedure.It was unknown how it was occurred.The procedure was completed.There was no delay reported.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) unk - nail head elements: pfna blade; this is report 2 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.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

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

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device history lot: part: 04.027.035s, lot: 50p4416, manufacturing site: bettlach, release to warehouse date: apr 9, 2020, expire date: apr 1, 2030.A manufacturing record evaluation was performed for the finished device 04.027.035s lot: 50p4416 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.

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: functional jammed/seized.Visual inspection: the received impactor is jammed/seized with the pfna blade as complained.Both devices show scratches and impression marks on several points.Furthermore, at the bottom of the impactor are hammer strikes visible.Functional test: the parts could not be separated.Consequently, an accurate functional test could not be performed.Dimensional inspection: the relevant dimensions cannot be verified, as the devices cannot be separated anymore.According to the manufacturing documents, the m7x1 threads of both lots passed the inspection steps, during manufacturing without any deviations.Drawing/specification review: the manufacturing review shows, that the production procedures were according to the specifications.And there were no issues that would contribute to this complaint condition.Failure in material or production could not be detected.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.However, this failure is typically consistent with inadequate handling of the device in combination with excessive force application.The hammer marks at the bottom of the impactor gives us an indication, that excessive force was applied on the device.Which is not the indented use.The surgical technique described to not use unnecessary force when inserting the pfna blade.Finally, we conclude that the cause of failure is not, due to any manufacturing non-conformances.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.Device history lot: part: 04.027.035s, lot#: 50p4416, manufacturing site: bettlach, release to warehouse date: apr 09, 2020, expire date: apr 01, 2030.A manufacturing record evaluation was performed, for the finished device 04.027.035s, lot#: 50p4416.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: PFNA BLADE PERF L100 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10863810
• MDR Text Key: 219373834
• Report Number: 8030965-2020-09040
• Device Sequence Number: 1
• Product Code: HRS
• 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,Followup,Followup,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.035S
• Device Lot Number: 50P4416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 02/26/2021
• Patient Sequence Number: 1
• Treatment: IMPACTOR F/PFNA BLADE