MAUDE Adverse Event Report: SYNTHES GMBH SCR Ø1.5 SELF-DRILL L6 TAN 1U I/CLIP; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 04.503.226.01C

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint cannot be confirmed.A definitive root cause could not be identified for the reported issue from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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.Device history lot lot # provided is not a valid number, therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.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, during the surgery the screwdriver did not hold the implant screws.This report is for (1) ti matrixmidface screw self-drilling 6mm.This report is 6 of 7 for (b)(4).

Manufacturer Narrative

Additional product code: jey.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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: SCR Ø1.5 SELF-DRILL L6 TAN 1U I/CLIP
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13060384
• MDR Text Key: 284509817
• Report Number: 8030965-2021-10394
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819908574
• UDI-Public: (01)07611819908574
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K050608
• 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

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: 04.503.226.01C
• Device Lot Number: 04.503.226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/12/2022
• 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
• Treatment: SCR Ø1.5 SELF-DRILL L4 TAN 1U I/CLIP; SCR Ø1.5 SELF-DRILL L4 TAN 1U I/CLIP; SCR Ø1.5 SELF-DRILL L6 TAN 1U I/CLIP; SCR Ø1.5 SELF-DRILL L6 TAN 1U I/CLIP; SCR Ø1.5 SELF-DRILL L6 TAN 1U I/CLIP; UNK - SCREWDRIVERS