MAUDE Adverse Event Report: SYNTHES GMBH CERCLAGE PASSER, DIVIDABLE FORCEPS, LRG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.221.011
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part #: 03.221.011, lot #: l551682, supplier: (b)(4), release to warehouse date: november 21, 2017.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the cerclage passer, dividable forceps, lrg (part #: 03.221.011, lot #: ll551682) was received at jrz pal.Visual inspection of the complaint device showed that one of the opened tips which allow the cable to pass through was deformed.The tip hole was bent causing that the circle to pass through was not properly formed, this can cause the impedance for the cable.No other issues were found.Functional test: a functional assessment was not performed with the complaint device since the cable was not returned and also due to the damage of the device.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: no dimensional inspection was performed due to the nature of the defect.Document/specification review: current and manufactured revisions.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed for the cerclage passer, dividable forceps, lrg (part #: 03.221.011, lot #: ll551682) as one of the opened tips which allow the cable to pass through was deformed.This condition causes impedance for the cable to pass through.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2021, during a procedure the instrument did not allow the cerclage cable to pass through properly.There was no surgical delay.There were no fragments generated.There was no patient consequence.This report involves one (1) cerclage passer, dividable forceps, large.This is report 1 of 1 for (b)(4).

• Brand Name: CERCLAGE PASSER, DIVIDABLE FORCEPS, LRG
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SYNTHES UMKIRCH (DE); im kirchenhürstle 4-6; umkirch bei freiburg 79224 ; GM 79224
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13367581
• Report Number: 8030965-2022-00572
• Device Sequence Number: 3991750
• Product Code: LXH
• UDI-Device Identifier: 10886982076731
• UDI-Public: (01)10886982076731
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Nurse
• 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 Model Number: 03.221.011
• Device Catalogue Number: 03.221.011
• Device Lot Number: L551682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2017
• 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: UNK - CABLE/WIRE: CERCLAGE CABLE
• Patient Sex: Unknown