MAUDE Adverse Event Report: SYNTHES GMBH 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.614.035
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pcf (c3-c6) for treating cervical damage on (b)(6), 2021, the drill bit broke.While the surgeon was adjusting screw insertion direction against the hardened bone, pressure was added to the drill bit, which lead to tip¿s breakage (approximately 16mm long).The fragmented tip was removed from the patient¿s body.Next, torque feature on the torque limitation handle became out of order during rod deployment.The procedure was completed with less than thirty minutes delay.No further information is available.This report is for a 2nm torque limiting handle with quick coupling.This is report 2 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Part: 03.614.035, synthes lot: 6652553, supplier lot: 6652553.Release to warehouse date: august 22, 2011.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The product was returned to us customer quality (cq) for evaluation.The device was sent to (b)(6) for torque testing.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that no defects were found with handle w/torq limit 2nm w/quick-coupl.The dimensional inspection was not performed as internal components were inaccessible without destruction of device.The functional test was performed by (b)(6) to check the specification of the device.The handle failed all torque evaluation steps and was noticeably running very rough.The device cannot be repaired.The received drill bit tip showed signs of usage on its cutting edges; it cannot be verified why it was broken apart and if it was linked to the event description but a torque of 4.6nm would cause the unintended forces on the drill bit and could result in the breakage.Thus device failed to function as intended.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for handle w/torq limit 2nm w/quick-coupl.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.Drawing/specifications reviewed the following drawing reflecting the current and manufacture revision was reviewed: -torque limiting handle quick coupling 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: 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13081889
• Report Number: 8030965-2021-10459
• Device Sequence Number: 4998356
• Product Code: LXH
• UDI-Device Identifier: 07611819968677
• UDI-Public: (01)07611819968677
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.614.035
• Device Lot Number: 6652553-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRILL BIT Ø2.4 W/STOP 2FLUTE; UNKNOWN SCREW -SPINE
• Patient Sex: Unknown