MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 2.7MM TI LOCKING SCR SLF-TPNG WITH T8 STARDRIVE RECESS-14MM; PLATE, FIXATION, BONE

Catalog Number 402.214S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/18/2021

Event Type  Injury  

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 for a surgery.During the surgery, when inserting the locking screw, the locking screw was broken slightly below the head.The fragment left in the patient¿s body.The surgery was completed successfully without any surgical delay.No further information is available.Concomitant devices reported: unknown plate (part# unknown, lot# unknown, quantity 1).Unk - torque devices: trauma (part# unknown, lot# unknown, quantity 1).This complaint involves (1) device.This report is for (1) unk - screws: locking.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; 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.

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- visual analysis of the returned sample revealed that lockscr ø2.7 head lcp2.4 self-tap l14 ta was broken off completely from little below the head, and remaining broken piece was not returned.No other issues were identified.The embedded condition of implant in the patient cannot be confirmed from the available information.The dimensional inspection was performed, and it is within the specification limit.The observed condition lockscr ø2.7 head lcp2.4 self-tap l14 ta in the device was consistent with a random component failure that may have been caused by exposure to unintended force.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed broken condition of the lockscr ø2.7 head lcp2.4 self-tap l14 ta.While no definitive root cause could be determined, it is probable that the lockscr ø2.7 head lcp2.4 self-tap l14 ta was broken during the surgery while applying additional torque by surgeon as mentioned.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.Device history lot : part #: 402.214s , synthes lot #: 7l89029, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 20 feb 2021, expiry date: 01 feb 2031.Non-sterile part: part #: 402.214, lot #: 91p1735.Dhr was performed and were no nc identified related to 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: 2.7MM TI LOCKING SCR SLF-TPNG WITH T8 STARDRIVE RECESS-14MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• 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: 12800597
• MDR Text Key: 280777609
• Report Number: 8030965-2021-09451
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819827301
• UDI-Public: (01)07611819827301
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 402.214S
• Device Lot Number: 7L89029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: TRAUMA; UNK - TORQUE DEVICES
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male