MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPARE REAMER TUBE FOR HOLLOW REAMER

Model Number	309.068
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is jnj representative.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 or Problem Description
It was reported that on (b)(6) 2020, in sterile processing department (spd) found several broken items that was used in a case yesterday.One (1) spare reamer tube for hollow reamer was grinded up and broken, one 2.7/3.5mm depth gauge and one (1) screwdriver for 4.5mm titanium multiloc screws were damaged.It is unknown if there were patient and procedure involvement.This complaint involves three (3) devices.This report is for (1) spare reamer tube for hollow reamer.This is report 1 of 1 for (b)(4).
Event or Problem Description
It was reported that on (b)(6) 2020, the sterile processing department (spd) found several broken items that were used and discovered post-operatively.One (1) spare reamer tube for hollow reamer was grinded and broken.One 2.7/3.5mm depth gauge and one (1) screwdriver for 4.5mm titanium multiloc screws were damaged.No procedural or patient information available.This is report 1 of 3 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.H3, h4, h6- the spare reamer tube for hollow reamer (part #: 309.068, lot #: 2091445) was received at us cq.Upon visual inspection, it was observed that a few of the teeth at the end of the device had broken off.The broken off teeth were not received at us cq.Additionally, a crack was observed to begin at the damaged teeth section of the device and continued up through the machined hole of the device.No other issues were identified.This complaint was confirmed as a few of the teeth at the end of the device had broken off.Additionally, a crack was observed to begin at the damaged teeth section of the device and continued up through the machined hole of the device.While no definitive root cause could be determined, it is possible the device encountered unintended forces during use.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 history lot part number: 309.068 (internal part number 36598), lot number: 2091445, manufacturing site: bettlach, release to warehouse date: 15.June 2004.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
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10434066
• Report Number: 2939274-2020-03705
• Device Sequence Number: 17061059
• Product Code: HTO
• UDI-Device Identifier: 10886982185587
• UDI-Public: (01)10886982185587
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 309.068
• Device Catalogue Number: 309.068
• Device Lot Number: 2091445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPTH GAUGE 2.7/3.5 0-60; DEPTH GAUGE 2.7/3.5 0-60; SCWDR F/4.5MM TI MLTLOC SCRWS/SLF-RTAN/330MM; SCWDR F/4.5MM TI MLTLOC SCRWS/SLF-RTAN/330MM