MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPAREREAMERTUBE F/309.450

Catalog Number	309.480
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn.As no product was received.Device was used for treatment, not diagnosis.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during decontamination on an unknown date, one (1) extra-bolt was found cracked and one (1) sparereamer tube was found broken.There were no surgical procedure and patient involvement.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: the device has been 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.
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.Part 5787 (309.480), lot 9387407: manufacturing site: (b)(4).Release to warehouse date: april 30, 2015.The device history record shows this lot of devices was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.The used material was stainless steel 1.4112 as required and the measured harness was within the specification.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.A product investigation was completed: the visual inspection has shown that one cutting tooth at the forefront is broken off.The broken piece was not sent back.The cutting edges of the remaining teeth are badly worn.The relevant dimensions close to the breakage were measure and found to meet the specifications.The manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The used material was stainless steel 1.4112 as required and the measured harness was within the specification.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.It is likely 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.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.Date of event is unknown.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: SPAREREAMERTUBE F/309.450
• Common Device Name: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8066472
• Report Number: 8030965-2018-58171
• Device Sequence Number: 19070098
• Product Code: HTO
• UDI-Device Identifier: 07611819018419
• UDI-Public: (01)07611819018419
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2018

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: 9387407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 12/04/2018; 12/13/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/04/2018; 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1