MAUDE Adverse Event Report: SYNTHES GMBH HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.120.022
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in canada as follows: it was reported that during an open reduction/internal fixation procedure on (b)(6), 2023, the surgeon was threading the h&le for percutaneous thrd drill guides into the threaded drill guides, and the handle for percutaneous threaded drill guides would thread but not retain the rigidness that the surgeon was used to achieving.The surgery was delayed by four minutes due to the event.A second set of instruments was opened in order to obtain another percutaneous threaded drill guide.The procedure was completed successfully and there was no patient consequence.This report involves one handle for percutaneous threaded drill guides.This is report 1 of 4 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E1: initial reporter telephone number reported as: (b)(6).H3, h4, h6: part: 03.120.022 lot: 8787773 manufacturing site: haegendorf release to warehouse date: 29.Jan.2014.The device history record shows this lot of 48 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that there was no significant product problem observed on the surface of h&le for percutaneous thrd drill guides, p/n: 03.120.022, lot: 8787773.The allegation of will not hold/retain, was not confirmed since the device was not returned for evaluation.Functionality issues can not be assessed through a photo investigation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for h&le for percutaneous thrd drill guides, p/n: 03.120.022, lot: 8787773.There is no indication that a design or manufacturing issue has caused the complaint condition 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: HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16762267
• Report Number: 8030965-2023-04807
• Device Sequence Number: 6151493
• Product Code: FZX
• UDI-Device Identifier: 10886982074201
• UDI-Public: (01)10886982074201
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 04/18/2023

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: 03.120.022
• Device Catalogue Number: 03.120.022
• Device Lot Number: 8787773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2014
• 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: 2.5 PERC WIRE GUIDE F/5.0 LCKNG SCREWS; 3.2MM PERCUTANEOUS THREADED DRILL GUIDE; 4.3MM PERCUTANEOUS THREADED DRILL GUIDE
• Patient Sex: Unknown