MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 6.0MM DRILL SLEEVE EXTRA LONG/OUTER; MISC ORTHO SURGICAL INSTR

Catalog Number	03.313.728
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: part number: 03.313.728, lot number: 138p532, manufacturing site: (b)(4), release to warehouse date: 21 may 2021.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient has infection after a tomofix surgery.It was unknown if there is any schedule for further procedure.The patient has consequences are reported.This complaint involves ten(10) devices.This report is for (1) 6.0mm drill sleeve extra long/outer.This report is 2 of 10 for (b)(4).
Event or Problem Description
The initial complaint was reviewed and found not reportable.The reported device is an instrument and there is no allegation against this device.

• Brand Name: 6.0MM DRILL SLEEVE EXTRA LONG/OUTER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13127378
• Report Number: 3000270450-2021-00008
• Device Sequence Number: 1581091
• Product Code: LXH
• UDI-Device Identifier: 07612334220387
• UDI-Public: (01)07612334220387
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 03.313.728
• Device Lot Number: 138P532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 12/31/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORTSCR Ø4.5 SELF-TAP L46 TI; LOCKSCR Ø5 SELF-DRILL L26 TAN; LOCKSCR Ø5 SELF-DRILL L26 TAN; LOCKSCR Ø5 SELF-DRILL L26 TAN; LOCKSCR Ø5 SELF-TAP L46 TAN; LOCKSCR Ø5 SELF-TAP L46 TAN; LOCKSCR Ø5 SELF-TAP L60 TAN; LOCKSCR Ø5 SELF-TAP L70 TAN; TOMOFIXTIBHEADPL MED PROX 4HO TI
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown