MAUDE Adverse Event Report: HAGENDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LOCKING SCREW SELF-TAPPING 18MM; APPLIANCE,FIXATION,NAIL

Catalog Number 413.018S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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 patient underwent removal of six (6) locking screws and one (1) clavicle plate due to discomfort from material under the skin.The original surgery took place on (b)(6) 2019.There was a thirty (30) minute surgical delay.No fragments were generated.The patient outcome was positive.There is no further information available.This report is for one (1) 3.5mm ti locking screw self-tapping 18mm.This is report 4 of 7 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.Device history lot part: 413.018s, lot: l635588, manufacturing site: grenchen, release to warehouse date: 20nov 2017, expiry date: 01 nov 2027.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.Alert date and awareness date were originally reported as may 3, 2021.The correct alert and awareness dates are may 26, 2021.

• Brand Name: 3.5MM TI LOCKING SCREW SELF-TAPPING 18MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): HAGENDORF SYNTHES PRODUKTIONS GMBH; im bifang 6; hagendorf 4614 ; SZ 4614
• MDR Report Key: 11901548
• MDR Text Key: 254582453
• Report Number: 8030965-2021-04407
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819268555
• UDI-Public: (01)07611819268555
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 413.018S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention