MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM CANNULATED SCREW PARTIALLY THREADED/14MM; SCREW,FIXATION,BONE

Model Number	205.040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: patient date of birth/age, sex and weight were not provided for reporting.Reportedly, device was implanted on (b)(6) 2018.It is unknown if the patient underwent explant procedure.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, patient underwent elbow reduction procedure.During the procedure, the partially threaded cannulated screw began to disintegrate and loses the thread upon insertion.There was a surgical delay of approximately an hour and thirty minutes.There was no patient harm reported.The procedure was completed successfully.This report is for one (1) 3.5mm cannulated screw partially threaded/40mm.(b)(4).
Additional Manufacturer Narrative
Additional narrative: patient ethnicity is unknown.Event or problem: information added.Corrected data: event or problem: length of surgical delay.(b)(4).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
Fragments generated from the disintegration were easily removed.No other medical intervention was required.There was a surgical delay of 45 minutes.
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.H10: additional narrative: h3, h4, h6: part 205.140, lot 9762463: manufacturing site: grenchen.Release to warehouse date: december 12, 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 raw material certificate was reviewed and the used material was according to specifications for implants for surgery.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.H3, h6: a product investigation was completed: visual inspection observed that the returned cannulated screw was broken at its tip portion.Furthermore, the thread of the screw was observed to be peeled off from its base shaft all over its length.No new issues were identified.The given device complaint condition is consistent with the complaint description and the observed condition was confirmed.Based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed.Dimensional inspection was not able to be performed on the returned device due to significant post manufacture breakage.A definitive root cause for the given complaint condition could not be determined from the provided information.However, it is likely that any unintended excessive off-axis forces during usage could have contributed given complaint condition.The overall complaint condition is confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H11: d6: device broke during insertion; device was not implanted/explanted.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.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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.G4: the date received by manufacturer for mwr-11062018-0000127042 (follow-up mw1) is june 11, 2018.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: 3.5MM CANNULATED SCREW PARTIALLY THREADED/14MM
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7577954
• Report Number: 8030965-2018-54181
• Device Sequence Number: 1524504
• Product Code: HWC
• UDI-Device Identifier: 10886982146892
• UDI-Public: (01)10886982146892
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K963192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/16/2018

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 Model Number: 205.040
• Device Catalogue Number: 205.140
• Device Lot Number: 9762463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 06/08/2018; 07/17/2018; 08/01/2018; 08/10/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/09/2018; 07/17/2018; 08/07/2018; 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1