MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM THREADED REDUCTION TOOL SELF-DRILLING 78MM HEX-STERILE; MISC ORTHO SURGICAL INSTR

Model Number	03.507.002S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
It was reported that on (b)(6) 2020, the 2.4mm threaded reduction tool self- drilling 78mm hex -sterile broke off in the patient's face.Switched to self-tapping carroll-gerard, left broken piece in the patient.The screw was not removed.No fragments generated.There were 30 minutes of surgical delay.The procedure successfully completed.The patient outcome is unknown.Concomitant device reported: unk - plates: matrixmid face (part # unknown; lot # unknown; quantity: unknown).This complaint involves one (1) device.This is 1 of 1 for report (b)(4).
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.H3, h4, h6: part number: 03.507.002s, synthes lot number: h408046, supplier lot number: n/a, release to warehouse date: 12sep2017, expiration date: 31jul2026, manufactured by synthes monument.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Visual inspection: the 2.4 mm threaded reduction tool self-drilling 78 mm hex-sterile (p/n: 03.507.002s, lot #: h408046) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the device was broken near the most proximal thread.The broken fragment was not returned and the complaint cannot be confirmed for the embedded device as no x-rays were provided.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.2.4 mm percutaneous reduction tool self-drilling, 78mm hex.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the 2.4 mm threaded reduction tool self-drilling 78 mm hex-sterile (p/n: 03.507.002s, lot #: h408046).There is no indication that a design or manufacturing issue has caused the issue 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.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: 2.4MM THREADED REDUCTION TOOL SELF-DRILLING 78MM HEX-STERILE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9832209
• Report Number: 2939274-2020-01273
• Device Sequence Number: 726841
• Product Code: LXH
• UDI-Device Identifier: 10887587014166
• UDI-Public: (01)10887587014166
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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 Expiration Date: 07/31/2026
• Device Model Number: 03.507.002S
• Device Catalogue Number: 03.507.002S
• Device Lot Number: H408046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.4MM THRDED RDCTION TL SLF-DRILNG 78MM HX-STRLE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR