MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM CANNULATED SCREW 32MM THREAD 60MM; SCREW, FIXATION, BONE

Model Number	208.434
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported patient was implanted with the 6.5mm cannulated screw on unknown date for unknown reason.It was further reported that the screw failed to hold compression/fixation.Patient was returned to surgery on (b)(6) 2018 and was revised to a variable angle (va) olecranon plate.Concomitant device reported: olecranon plate (part number unknown, lot number unknown, quantity 1) this report is for one (1) 6.5mm cannulated screw.This is report 1 of 1 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.Additional narrative: event: updated.Corrected data: date rec¿d by mfr: should have been reported as 8/2/2018 instead of 8/3/2018 in initial mw report, mwr:16082018-0000175907.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
It was further reported that he compression needed for the 6.5 cannulated screw was not achieved during its implantation and the bone was not healing.Therefore, on (b)(6) 2018, a second surgery was required to remove the cannulated screw and a synthes variable angle olecranon plate was placed on the olecranon bone for fixation.

• Brand Name: 6.5MM CANNULATED SCREW 32MM THREAD 60MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7802220
• Report Number: 2939274-2018-53415
• Device Sequence Number: 2726057
• Product Code: HWC
• UDI-Device Identifier: 10886982149398
• UDI-Public: (01)10886982149398
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K021932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 208.434
• Device Catalogue Number: 208.434
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/24/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 96