MAUDE Adverse Event Report: SYNTHES GMBH SPAREREAMERTUBE F/309.035

Catalog Number	309.038
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
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.Additional narrative: a manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.¿the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.¿ ¿visual analysis of the returned sample revealed that the sparereamertube has broken, a couple of fragments was returned.No other problems was reported.A dimensional inspection was not performed for the sparereamertube due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.¿as part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.¿ ¿the overall complaint was confirmed as the observed condition of the sparereamertube would contribute to the complained device issue.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.
Event or Problem Description
Device report from depuy synthes reports an event in switzerland as follows: it was reported that during a procedure on (b)(6) 2022, while extracting a cold welded 3.5 mm locking head screw from philos plate, the conical extraction screw did not work.Carbide drill was used to take off the screw head and then plate could be removed.The remaining screw shaft was overdrilled and drill intramedullary disrupted.All fragments of the instrument could be removed.There was a fifteen (15) minutes of surgical delay.The procedure was successfully completed.There was no patient consequence.This report is for one (1) spare reamer tube for hollow reamer this is report 2 of 2 for complaint (b)(4).

• Brand Name: SPAREREAMERTUBE F/309.035
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES BME : SAN ANTONIO; 14785 omicron drive; #205; san antonio TX 78245
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15064541
• Report Number: 8030965-2022-04990
• Device Sequence Number: 5307752
• Product Code: HTO
• UDI-Device Identifier: 07611819201866
• UDI-Public: 07611819201866
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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

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: 309.038
• Device Lot Number: 64P5197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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-SCREW CONI F/SCR Ø2.7 3.5+4
• Patient Age: 70 YR
• Patient Sex: Female