MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM; PLATE, BONE

Model Number	04.503.640.01
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Post-operative; unknown when event occurred.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(6) 2022 the surgeon removed the implants from the first surgery as the implants were damaged inside the patient.No information is known on patient status.This is report 2 of 3 for (b)(4).This report is for 2.4mm ti matrixmandible locking screw slf-tpng 10mm.
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.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: 15l2627, lot quantity: (b)(4).Lot summary report dated 21-aug-2019 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Note: there were no supplier material certifications included in this dhr.Supplier was notated as dynamet.Packaging bom was reviewed and found 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.Manufacturing location: monument manufacturing date: 27-nov-2019 part number: 04.503.640.01c, 2.0mm ti matrixmandible locking screw slf- tpng 10mm lot number: 27p8034 (non-sterile) lot quantity: (b)(4).The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the lock scr ø2.4 self-tap l10 tan 1u i/clip.Only was observed signs of usage and normal worn which could have been a result of implantation and explantation.No broken condition was found.A dimensional inspection was performed for the lock scr ø2.4 self-tap l10 tan 1u i/clip and met specifications.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the lock scr ø2.4 self-tap l10 tan 1u i/clip was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM
• 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: 15543299
• Report Number: 8030965-2022-07876
• Device Sequence Number: 14918274
• Product Code: JEY
• UDI-Device Identifier: 10887587022161
• UDI-Public: (01)10887587022161
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• 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: 04.503.640.01
• Device Catalogue Number: 04.503.640.01C
• Device Lot Number: 27P8034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2019
• 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: IMF SCREW Ø2 L8 SST; IMF SCREW Ø2 L8 SST; LOCK SCR Ø2.4 SELF-TAP L10 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L12 TAN 1U I/CLIP; MATRIXMAND RECO-PL ANGL R 7+23HO T2.5 TI
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male