MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPARE REAM TUBE HOLLOW REAM (309.450); REAMER

Catalog Number	309.480
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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 india as follows: it was reported that on (b)(6) 2020 during lcp proximal tibia plate removal surgery, the spare reamer tube, extraction bolt, and conical extraction screw were broken and nonfunctional.There was a surgical delay of thirty (30) minutes.The procedure was successfully completed using other instruments.There was no patient consequence.This report is for one (1) spare reamer tube for hollow reamer (309.450).This is report 1 of 3 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.D9: complained device is no longer expected to be returned for investigation.H3, h4, h9: part 309.48, lot 2188594: manufacturing site: bettlach.Release to warehouse date: march 30, 2006.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
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.Visual inspection: the spare ream tube hollow ream (p/n: 309.480, lot #: 1l12133) was returned for analysis.Visual inspection of the returned device found a broken condition, one of the fragments was received in the package.Deformed condition was found at the tip of the device.Additionally, during physical evaluation corrosion was identified inside the shaft of the device.Dimensional inspection: dimensional inspection cannot be performed due to post manufacturing damage.Investigation conclusion: the reported condition of the complaint device (the spare ream tube hollow ream) is confirmed.Device is broken and deformed.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 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 - 01/26/2022.Part/lot combination (part # 309.480 lot# 1l12133) is not valid, therefore the dhr could not be completed.If the device is returned or the lot number is confirmed the dhr will be revisited.Part number: 309.48.Lot number: 2188594.Manufacturing site: bettlach.Release to warehouse date: 30.Mar.2006.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: SPARE REAM TUBE HOLLOW REAM (309.450)
• Common Device Name: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10831578
• Report Number: 8030965-2020-08902
• Device Sequence Number: 3644756
• Product Code: HTO
• UDI-Device Identifier: 07611819018419
• UDI-Public: (01)07611819018419
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup,Followup
• Report Date (Section B): 10/18/2020

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: 309.480
• Device Lot Number: 1L12133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/18/2020
• Supplement Date Received by Manufacturer: 01/05/2021; 02/09/2022
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 01/06/2021; 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2006
• 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: EXTRACT-BOLT F/SCR Ø4.5+5; EXTRACT-SCREW CONI F/SCR Ø4.5+6.5
• Patient Sex: Unknown