MAUDE Adverse Event Report: SYNTHES GMBH SHAFT FOR 90 SCREWDRIVER; SCREWDRIVERS

Catalog Number 03.505.003

Device Problem Failure to Discharge (1169)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: dzi dzj.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter is a j&j representative.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 synthes reports an event in (b)(6) as follows: it was reported from the j&j¿s distribution center on (b)(6) 2021, that the shaft was not able to detach from the screwdriver shafts in question.No further information is available.This complaint involves three (3) devices.This report is for (1) shaft for 90 screwdriver this report is 3 of 3 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.H10 additional narrative: d7a; d9, h3, h6: the subject device has been 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.H3, h4, h6: the customer complaint was not confirmed.This investigation was performed based only on the photo provided.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 # 03.505.003.Lot # 8213959.Manufacturing site: selzach.Release to warehouse date: 14 oct2021.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.,part #: 03.505.003.Lot #: 8213959.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 14 oct 2021.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6- the customer complaint was not confirmed.This investigation was performed based only on the photo provided.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.,product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot
=
> part #: 03.505.003 lot #: 8213959 manufacturing site: selzach supplier: diener ag precision machining release to warehouse date: 01 jun 2017 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.,part # 03.505.003 lot # 8213959 manufacturing site: selzach release to warehouse date: 14 oct2021 supplier: diener ag precision machining a manufacturing record evaluation was performed for the finished article lot 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: SHAFT FOR 90 SCREWDRIVER
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13003761
• MDR Text Key: 285351006
• Report Number: 8030965-2021-10213
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 0887587013299
• UDI-Public: (01)0887587013299
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082649
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.003
• Device Lot Number: 8213959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 12/29/2021; 02/09/2022; 02/10/2022
• Supplement Dates FDA Received: 01/28/2022; 02/10/2022; 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• 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
• Treatment: SHAFT FOR 90 SCREWDRIVER; SHAFT FOR 90 SCREWDRIVER