MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM UNIVERSAL DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Model Number	323.26
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: initial reporter is a j&j sales representative.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.It was reported that while cleaning and taking apart item 2.7mm universal drill guide, the sterile processing technician noticed some rust looking residue on the drill guide, and spring.When they tried to scrub it with a wire brush, the spring began to disintegrate and was unable to remove all the rust from this item.The repair technician reported that the spring deformed with rust, drill sleeve rusted and the tip is wider.Also the device failed cosmetics and part functional tests.The cause of the issue is damaged component.The following parts were replaced: 2.0 mm drill sleeve and compression spring.The item was repaired per the inspection sheet, passed synthes final inspection on 04-apr-2022 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.The device was deemed serviceable and returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.Device history lot: part #: 323.260-us, lot #: 8798443, manufacturing site: (b)(4), release to warehouse date: 14 feb 2016, expiration date: n/a.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 reports an event in the usa as follows: it was reported that on an unknown date, while cleaning and taking apart item the sterile processing tech noticed some rust looking residue on the drill guide, and spring.She said she tried to scrub it with a wire brush but when she did the spring began to disintegrate and she was unable to remove all the rust from this item.The patient did not experience any post-op device malfunction.No revision surgery was required.No patient outcome status was reported.This complaint involves one device 2.7mm universal drill guide.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.7MM UNIVERSAL DRILL GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14345395
• Report Number: 2939274-2022-01688
• Device Sequence Number: 5270710
• Product Code: FZX
• UDI-Device Identifier: 10886982190796
• UDI-Public: (01)10886982190796
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2022

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: 323.26
• Device Catalogue Number: 323.26
• Device Lot Number: 8798443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2016
• 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
• Patient Sex: Unknown