MAUDE Adverse Event Report: SYNTHES GMBH EXTRACTION SCREW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 357.360

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/17/2023

Event Type  malfunction  

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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h6: 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 germany as follows: it was reported that on (b)(6) 2023, during inspection in the loaner department, the following product deviation was identified: the instrument´s thread is defect after second use.The product was not complained by any customer.There is no patient impact, no surgery delay and no customer impact.This report involves one (1) extraction screw.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device visual analysis of the provided photo revealed the threaded tip of the extractscr f/ufn/cfn+spiral blade was worn.No other problem identified.According to event description, the items has only been used 2 times, and since the device was manufactured on january 2023, it is probable that the device was not used as intended or mated with devices that are not within the instructions for use.The observed condition is consistent with the rotating bending fatigue from striking the end cap off-axis, possibly in multiple various directions or the extraction assembly was over-tightened.The ufn unreamed femoral nail/cfn cannulated femoral nail surgical technique was reviewed.Following relevant statement was found.Instructions of use: manually thread the extraction screw (357.360) into the hub of the spiral blade, and secure the screw using the pin wrench b 4.5 mm (321.170).Thread the hammer guide (357.220) and slide hammer (357.250) into the extraction screw.Extract the spiral blade.Maintain a loose grip on the extraction assembly so that it can rotate with the blade during extraction.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for extractscr f/ufn/cfn+spiral blade.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.Part number: 357.360.Lot number: 4226p45.Manufacturing site: haegendorf.Release to warehouse date: 27th january 2023.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.

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 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 device found that the extractscr f/ufn/cfn+spiral blade was worn.No other issues were observed.According to event description, the items has only been used 2 times, and since the device was manufactured on january 2023, it is probable that the device was not used as intended or mated with devices that are not within the instructions for use.The observed condition is consistent with the rotating bending fatigue from striking the end cap off-axis, possibly in multiple various directions or the extraction assembly was over-tightened.The ufn unreamed femoral nail/cfn cannulated femoral nail surgical technique was reviewed.Following relevant statement was found.Instructions of use: manually thread the extraction screw (357.360) into the hub of the spiral blade, and secure the screw using the pin wrench b 4.5 mm (321.170).Thread the hammer guide (357.220) and slide hammer (357.250) into the extraction screw.Extract the spiral blade.Maintain a loose grip on the extraction assembly so that it can rotate with the blade during extraction.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.A dimensional inspection for the extractscr f/ufn/cfn+spiral blade was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the extractscr f/ufn/cfn+spiral blade would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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: EXTRACTION SCREW
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): HAEGENDORF; im bifang 6; haegendorf CO 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17571676
• MDR Text Key: 321644374
• Report Number: 8030965-2023-10410
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.360
• Device Lot Number: 4226P45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1