MAUDE Adverse Event Report: SYNTHES GMBH EXTRACTSCR F/A2FN; EXTRACTOR

Catalog Number 03.010.373

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problems Bone Fracture(s) (1870); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/29/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that a case went ahead on (b)(6) march at the (b)(6) hospital where the surgeon was performing the removal of a femoral nail.I received a call during the procedure asking for help with the equipment as the surgeon was having a difficult time with the nail removal loan set znautr0169 in the attempt to remove the 9mmx360mm right side a2fn femoral nail from depuy synthes (product code 04.009.252s).The surgeon stated after the case that he believes the instruments were too old and potentially worn and not engaging correctly.As a result the surgeon had to make an incision at the patient's knee and then open an access point at the distal femur and push the nail out from the distal access point.This complaint involve one (1) device extractscr f/a2fn.This is report 1 of 1 for complaint (b)(4).

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.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.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.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.

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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the threaded tip of the extractscr f/a2fn has stripped, this condition can cause problems assembling in the instrument.The observed condition was consistent as an end of life indicator for the device.No other issues where identified.After a visual inspection per guidance provided in windchill document, it was determined that the reusable instrument device was worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed stripped of the extractscr f/a2fn would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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.Drawing/specifications reviewed: yes, no issues.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo revealed that the extractscr f/a2fn appears to be stripped from the threaded tip.Assembling issues are most likely due to this condition.Device history part number: 03.010.373, lot number: 18p8962 , manufacturing site: haegendorf , release to warehouse date: 03 october 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A manufacturing record evaluation cannot be performed since lot number is unknown.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.H10 additional narrative: h3, h6: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the extractscr f/a2fn appears to be stripped from the threaded tip.Assembling issues are most likely due to this condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the extractscr f/a2fn.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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.H6 health effect - clinical code 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

The nail was being removed because the fracture had healed and they were preparing for a subsequent knee replacement operation.

• Brand Name: EXTRACTSCR F/A2FN
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14192600
• MDR Text Key: 289962184
• Report Number: 8030965-2022-02656
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819327009
• UDI-Public: (01)07611819327009
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.373
• Device Lot Number: 18P8962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 05/10/2022; 06/13/2022
• Supplement Dates FDA Received: 06/07/2022; 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention