MAUDE Adverse Event Report: SYNTHES GMBH TI LOW PROFILE NEURO SCR SELF-DRILLING 5; PLATE, BONE

Model Number	400.835E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device broke during insertion; device not considered implanted/explanted complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during a skull repair surgery on (b)(6), 2022, a screw broke intraoperatively during insertion.Three (3) additional screws were used with breakage occurring each time.No fragments remained behind in the patient.Another device was used to complete the surgery.There were no adverse consequences to the patient.No surgical delay was reported.This is report 1 of 4 for (b)(4).This report is for a neuro screw.
Additional 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.H6: the photo was returned to depuy synthes for evaluation.Visual analysis of the photo revealed that the ti low profile neuro scr self-drilling 5 was found to be broken from the threaded body, fragment is not visible in the evidence provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the ti low profile neuro scr self-drilling 5.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that 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.H6: a device history record (dhr) review was conducted: manufacturing location: (b)(4) manufacturing date: 05-oct-2019.Part number: 400.835, ti low profile neuro screw self-drilling 5mm.Lot number: 17p5562 (non-sterile).Lot quantity: (b)(4).One piece was scrapped in cell at op, flow inspect/pack, for a damaged thread- debris.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, inspect dimensional, met all inspection acceptance criteria apart from the one piece noted.Packaging label log (pll) lmd was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 21015, tialnbri4.00.Lot number: 3l33328.Lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Certified test report was reviewed and determined to be conforming.Lot summary report dated 28-may-2019 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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: TI LOW PROFILE NEURO SCR SELF-DRILLING 5
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14056767
• Report Number: 8030965-2022-02322
• Device Sequence Number: 4747324
• Product Code: JEY
• UDI-Device Identifier: 10887587045450
• UDI-Public: (01)10887587045450
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 400.835E
• Device Catalogue Number: 400.835E
• Device Lot Number: 17P5562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown