MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9 TI CANNULATED HUMERAL NAIL-EX/300-SILE; NAIL,FIXATION,BONE

Model Number	04.001.440S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Physical Asymmetry (4573)
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.Reporter is a j&j representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device history lot: part #: 04.001.440s, synthes lot #: 7119218, release to warehouse date: 01 jan 2013, expiration date: 25 dec 2021, manufactured by: (b)(4), supplier: früh (b)(4), no ncr's generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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) 2021, the patient underwent revision surgery due to implants used causing the patient to lose reduction of the bone.It was unknown if the revision surgery completed successfully.It is unknown if there was a surgical delay.The patient status is unknown.This complaint involves five (5) devices.This report is for (1) 9 ti cannulated humeral nail-ex/300-sile.This is report 1 of 5 for (b)(4).

• Brand Name: 9 TI CANNULATED HUMERAL NAIL-EX/300-SILE
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12869398
• Report Number: 2939274-2021-06804
• Device Sequence Number: 14345606
• Product Code: JDS
• UDI-Device Identifier: 10886982081117
• UDI-Public: (01)10886982081117
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

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 Expiration Date: 12/25/2021
• Device Model Number: 04.001.440S
• Device Catalogue Number: 04.001.440S
• Device Lot Number: 7119218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.0 TI LCKNG SCR T25 SD 28 F/IM NAILS-S; 4.0 TI LCKNG SCR T25 SD 30 F/IM NAILS-S; 4.0 TI LCKNG SCR T25 SD 46 F/IM NAILS-S; TI SPIRAL BLD 42-S FOR TI HUMERAL NAILS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown