MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPARE REAMER TUBE FOR HOLLOW REAMER (309.065)

Catalog Number 309.068

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported two reamer tubes were broken.It is unknown when the malfunction occurred.It is unknown if there was patient involvement.This is report 2 of 2 for (b)(4).

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.Visual inspection: the visual inspection has shown that one cutting tooth at the forefront is broken off.The broken-off portion was not returned for evaluation.The cutting edges of the remaining teeth are worn.Dimensional inspection: the relevant dimensions close to the breakage were measured with caliper ref.3-01-20766 and found to meet the specifications from drawing: outer diameter specification: 9.0 +0/-0.10 mm, dimension measured: 8.97mm, result: pass.Core diameter: specification: 7.2 +0.05 /+0.10 mm, dimension measured: 7.25mm, result: pass.Document/specification review: drawing was reviewed during this investigation.The review of the manufacturing document has shown that with 1.4112 stainless steel (hardened and tempered) the correct material was used, and that the hardness was within the specification of 620 ¿ 720 hv10 from drawing.Summary: the complaint condition is confirmed as one cutting tooth is broken off.This production lot (l747189) was manufactured in april 2018 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The correct material was used, and the hardness parameters were within the specifications.The fracture face is homogenous, which indicates material conformity as well.There were no issues during the manufacture of this product that would contribute to this complaint condition.The damage occurred is determined to be post production/acceptance criterias.There was no information provided how or when the reamer broke or if a power tool was used, this makes it impossible to determine an exact root cause.We can only assume that an excessive contact between the reamer and a screw, for example by too much lateral stress during the removal of a screw, caused a mechanical overload and finally the breakage.We would like to point out that further information / precaution hints can be found in the respective extraction screw set handling technique based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot number l747189 belongs to article 36598, which is a sub component of 309.068.Dhr will be performed with following article and lot number combination.Part: 36598, lot: l747189, manufacturing site: bettlach, release to warehouse date: 06.Apr.2018.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 REAMER TUBE FOR HOLLOW REAMER (309.065)
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9511617
• MDR Text Key: 194100895
• Report Number: 8030965-2019-71374
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819201873
• UDI-Public: (01)07611819201873
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309.068
• Device Lot Number: L747189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1