MAUDE Adverse Event Report: SYNTHES GMBH WASHER Ø13/6.6 F/SCR Ø4.5-7.3 TI; WASHER, BOLT NUT

Catalog Number 419.990S

Device Problem Break (1069)

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

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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.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 that on (b)(6) 2021, the washer was broke during conventional tightening.This report is for one (1) washer ø13/6.6 f/scr ø4.5-7.3 ti.This is report 1 of 1 for complaint (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.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

Additional event description: the surgery was completed successfully with 30-munites delay.There were no fragments are remaining in the patient.The patient outcome was stable.

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 complaint device washer ø13/6.6 f/scr ø4.5-7.3 ti (product code: 419.990s, lot: 184p321) was not received for investigation.A photo investigation was performed the images were reviewed, and the complaint is confirmed, the image shows the washer was broken.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot : part: 419.990s, lot: 184p321, manufacturing site: raron, release to warehouse date: 23.Jun.2021, expire date: 01.Jun.2031.A manufacturing record evaluation was performed for the finished device 419.990s, lot: 184p321 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: WASHER Ø13/6.6 F/SCR Ø4.5-7.3 TI
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12720239
• MDR Text Key: 284835790
• Report Number: 8030965-2021-09124
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 07611819270046
• UDI-Public: (01)07611819270046
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2021

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: 419.990S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 10/29/2021
• Supplement Dates Manufacturer Received: 11/15/2021; 12/02/2021
• Supplement Dates FDA Received: 11/17/2021; 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1