MAUDE Adverse Event Report: SYNTHES GMBH WASHER 13.0MM; WASHER, BOLT NUT

Catalog Number 419.99

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, a closed reduction internal fixation procedure for a sub-capital femoral head fracture was performed.During the surgery, the surgeon heard a snapping sound and saw that the washer for the cannulated titanium screws was broken.The surgeon decided to leave the broken washer in the patient.No surgical delay reported.The procedure was successfully completed.This report is for one (1) washer 13.0mm this is report 1 of 1 for (b)(4).

Manufacturer Narrative

Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: WASHER 13.0MM
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12805785
• MDR Text Key: 285052710
• Report Number: 8030965-2021-09496
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 07611819031807
• UDI-Public: (01)07611819031807
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 419.99
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female