MAUDE Adverse Event Report: SYNTHES GMBH 6.0MM/5.0MM THREADED DRILL SLEEVE-SHORT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	395.921
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.Part: 395.921, lot: 4l24092, manufacturing site: (b)(4), release to warehouse date: may 29, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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) 2020, the patient underwent the open reduction internal fixation surgery with the sleeve and 2seldrills.During the surgery, when the surgeon inserted the seldrill with the 3 cm sleeve, the seldrill stuck into the sleeve due to the bone waste.The surgeon was able to disconnect the seldrill from the sleeve and attempted to connect a second seldrill to the sleeve.The second seldrill stuck into the sleeve.The surgeon disconnected the sleeve and removed the sleeve and seldrill from the patient¿s body.Another device was used to complete the surgery.There was thirty (30) minute surgical delay.The procedure was completed successfully.Concomitant devices reported: seldrill-schanzscr ø5 l175/60 ti (part number 494.785s, lot 6l97621, quantity 1).This report involves one (1) 6.0mm/5.0mm threaded drill sleeve-short.This is report 1 of 1 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 h3, h6: a product investigation was conducted.An seldrill¿ schanz screw and a drill sleeve were returned to depuy synthes for evaluation.Depuy synthes conducted a visual inspection and functional test of the returned devices.The visual inspection has shown that an seldrill¿ schanz screw is completely stuck in the drill sleeve.All features related to the reported complaint condition were reviewed and no other issues were identified.A functional test cannot be performed due to the stuck / jammed condition of the schanz screw in the drill sleeve it was not possible to separate these two part.The relevant dimensions (inner diameter) can not be verified due to the condition of these two parts.The damages are clearly caused post manufacturing.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, material and visual criteria at the time of release with no issues documented during the manufacturing process.No nc's were generated during the production of the lot in question.As part of depuy synthes¿ quality process all devices are manufactured, inspected, and released to approved specifications.The received condition agree with the complaint description and the complaint therefore is confirmed.The investigation has shown that an seldrill¿ schanz screw is completely stuck in the drill sleeve.The root cause for this jammed condition can not be clearly determined.Multiple factors can lead to technical difficulties of removal of these parts.These factors include, but are not limited to: too high rotational speed which lead to an cold-welding between these two parts or before drilling the parts are damage (for example: bent during using) or wrong angulation of the schanz screw during insertion, which could lead to the complaint condition.Based on the findings above and the condition of the device, we can confirm that no manufacturing related issue could be found which could have caused or contributed to the reported malfunction.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance 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.G1.

• Brand Name: 6.0MM/5.0MM THREADED DRILL SLEEVE-SHORT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11096584
• Report Number: 8030965-2020-10046
• Device Sequence Number: 824368
• Product Code: LXH
• UDI-Device Identifier: 07611819739055
• UDI-Public: (01)07611819739055
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: 395.921
• Device Lot Number: 4L24092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/05/2021
• 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: SELDRILL-SCHANZSCR Ø5 L175/60 TI